What is the purpose of the FDA's REMS program?

The FDA's Risk Evaluation and Mitigation Strategies (REMS) program is specifically designed to ensure that the benefits of a drug outweigh its risks for patients. This program is utilized for medications that have significant safety concerns and requires that additional measures are put in place beyond the standard labeling and patient information to communicate and mitigate these risks effectively.

Through REMS, the FDA can enforce requirements such as communication plans, restrictions on who can dispense the medication, and monitoring of patient use. These measures are intended to facilitate informed decision-making regarding the use of certain medications, particularly in situations where the potential for serious adverse effects exists. By doing so, the REMS program plays a crucial role in protecting public health while allowing beneficial medications to remain accessible under controlled circumstances.